Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Enforcement
- Recall Number
- Z-1389-2019
- Event ID
- 82638
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Collagen Matrix, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 29, 2019
- Initiation Date
- March 19, 2019
- Classification Date
- May 22, 2019
- Termination Date
- May 12, 2020
- Address
- 110 Commerce Dr, N/A, Allendale, NJ, 07401-1622, United States
Description
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
45 units -US;170 units OUS